NCT03943615
No Longer Available
Not Applicable
An Open-Label, Expanded Access Protocol for Patients With Sickle Cell Disease Who Have No Alternative Treatment Options
ConditionsSickle Cell Disease
DrugsVoxelotor
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sickle Cell Disease
- Sponsor
- Pfizer
- Locations
- 18
- Status
- No Longer Available
- Last Updated
- 2 years ago
Overview
Brief Summary
The intent of this open-label, multicenter expanded access program (EAP) is to provide early access to voxelotor prior to market authorization
Detailed Description
The purpose of this program is to provide early access to voxelotor for patients with sickle cell disease who have exhausted alternative treatment options and are ineligible for actively-recruiting clinical trials of voxelotor. This EAP may continue until such time that voxelotor is commercially available or the Sponsor discontinues the voxelotor EAP. Discontinuation may occur earlier if an individual participant or physician or Sponsor Medical Monitor decides to discontinue treatment.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Not specified
Study Sites (18)
Loading locations...
Similar Trials
Approved For Marketing
Not Applicable
An Expanded Access Study of Atezolizumab in Participants With Locally Advanced or Metastatic Urothelial Carcinoma After Failure With Platinum-Containing ChemotherapyUrothelial CarcinomaNCT02589717Genentech, Inc.
Approved For Marketing
Not Applicable
An Expanded Access Program of Emicizumab in Participants With Hemophilia A With InhibitorsHemophilia ANCT03154437Genentech, Inc.
Approved For Marketing
Not Applicable
An Open-Label, Multi-Center, Expanded Access Program With Eribulin for the Treatment of Advanced Breast Cancer RefractoryMetastatic Breast CancerNCT01240421Eisai Inc.
Approved For Marketing
Not Applicable
BMN 110 US Expanded Access ProgramMucopolysaccharidosis IVAMorquio A SyndromeMPS IVANCT01858103BioMarin Pharmaceutical
Active, not recruiting
Not Applicable
An expanded access program of ranibizumab in patients with visual impairment due to diabetic macular edema for whom no suitable therapeutic alternatives exist.EUCTR2011-002731-26-ITOVARTIS FARMA700